Methylphenidate Hydrochloride Extended-Release Tablets
»Methylphenidate Hydrochloride Extended-Release Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of methylphenidate hydrochloride (C14H19NO2·HCl).
Packaging and storage—
Preserve in tight containers.
Identification—
Place a portion of powdered Tablets,equivalent to about 100mg of methylphenidate hydrochloride,in a 100-mLbeaker.Add 20mLof chloroform,stir for 5minutes,and filter,collecting the filtrate.Evaporate the filtrate to about 5mL.Add ethyl ether slowly,with stirring,until crystals form.Filter the crystals,wash with ethyl ether,and dry at 80
for 30minutes:the IRabsorption spectrum of a mineral oil dispersion of the crystals so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Methylphenidate Hydrochloride RS.
for 30minutes:the IRabsorption spectrum of a mineral oil dispersion of the crystals so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Methylphenidate Hydrochloride RS.
Drug release á724ñ—
Medium:
water;500mL.
Apparatus 2:
50rpm.
Times:
1hour;2hours;3.5hours;5hours;7hours.
Procedure—
Determine the amount of methylphenidate hydrochloride (C14H19NO2·HCl)dissolved,employing the procedure set forth in the Assay,making any necessary volumetric adjustments.
Tolerances—
The percentages of the labeled amount of C14H19NO2·HCl dissolved at the times specified conform to Acceptance Table 1.
| Time (hours) | Amount dissolved |
| 1 | between 25%and 45% |
| 2 | between 40%and 65% |
| 3.5 | between 55%and 80% |
| 5 | between 70%and 90% |
| 7 | not less than 80% |
Uniformity of dosage units á905ñ:
meet the requirements.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1267
Pharmacopeial Forum:Volume No.30(4)Page 1263
Phone Number:1-301-816-8330